Smoking: a Risk Factor for Pulmonary Arterial Hypertension? (DACH)

Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)

Environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. One widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. The existing studies which deal with this subject are only small single center case control studies providing less data. Therefore a large European multicenter study is necessary.

The investigators hypothesis are:

• a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to the unaffected general population.
• a history of tobacco smoke exposure is more prevalent in patients with PAH compared to CTEPH.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • University Hospital of Graz
  • Innsbruck, Austria
    • University Hospital of Innsbruck
• Germany
  • Dresden, Germany
    • University Hospital Dresden
  • Greifswald, Germany
    • University of Greifswald
  • Heidelberg, Germany
    • University Hospital of Heidelberg
  • Homburg, Germany
    • University hospital of Homburg
  • Regensburg, Germany
    • University Hospital of Regensburg
  • Würzburg, Germany
    • University Hospital of Würzburg
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients seen at participating DACH -PH centers who have PH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤15mmHg will be asked to participate upon written informed consent

Description

Inclusion Criteria:

• pulmonary artery pressure >25mmHg
• pulmonary capillary occlusion pressure ≤15mmHg

Exclusion Criteria:

• pulmonary artery pressure <25mmHg
• pulmonary capillary occlusion pressure >15mmHg

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
PAH; Patients with pulmonary arterial hypertension (PH). PH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg
CTEPH; Patients with chronic thromboembolic pulmonary hypertension. CTEPH defined as mean pulmonary artery pressure >25mmHg with a pulmonary capillary occlusion pressure ≤ 15mmHg.
Controll group; Data from 16322 (10336 females) participants of the Swiss health survey (SHS) 2007 will serve as control. The SHS was performed in 2007, a representative sample of 30000 Swiss citizens were asked to participate, 66% answered per telephone to detailed health question.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population	Patients will be asked with a specific questionnaire concerning their tobacco smoke exposure and smoking history. Control-group: Data from Swiss health survey (SHS) 2007 (Gesundheitsbefragung Schweiz).	Assessment during outpatient consultation, an expected average of 1 day.

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, MD, Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: smoking; Chronic thromboembolic pulmonary hypertension; Pulmonary arterial Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: DACH_1